This invention relates generally to medical devices and methods of performing surgical procedures and more particularly to the anastomosis of blood vessels, ducts, lumens or other tubular organs.
Arterial bypass surgery is a common modality for the treatment of occlusive vascular disease. Such surgery typically involves a formal surgical incision and exposure of the occluded vessel followed by the joinder of a graft, e.g., a mammary artery, saphenous vein, or synthetic graft (all collectively referred to hereinafter as the "bypass graft"), to the occluded vessel(hereinafter the "native" blood vessel) distally (downstream) of the occlusion. The upstream or proximal end of the bypass graft is secured to a suitable blood vessel upstream of the occlusion, e.g., the aorta, to divert the flow of blood around the blockage. Other occluded or diseased blood vessels, such as the carotid artery, may be similarly treated. Moreover, similar procedures are conducted to place a graft between an artery and a vein in dialysis patients.
While such surgical procedures are widely practiced they have certain inherent operative limitations. For example, sewing the graft to the host vessel, known as anastomosis, requires complex and delicate surgical techniques to accomplish the optimum result. Various complications must be avoided when anastomosing a bypass graft, whether it be a natural graft or a synthetic graft. For example, it is important that the juncture between the native vessel and the bypass graft form a smooth uniform transition without narrowing or regional irregularities which could tend to reduce blood flow. Moreover, any protuberances into the lumen could obstruct blood flow and may produce turbulence, thereby increasing the risk of clotting and/or restenosis. In addition, the difference in size between the typically larger internal diameter of the bypass graft and the typically smaller native artery may also produce unwanted turbulence in the blood. All of these characteristics can greatly diminish the effectiveness and patency of the graft.
Various devices and methods of use have been disclosed for effecting anastomosis of blood or other vessels, ducts, lumens or other tubular organs. Examples of such devices and methods are found in U.S. Pat. Nos. 2,127,903 (Bowen), 3,155,095 (Brown), 3,588,920 (Wesolowski), 3,620,218 (Schmitt et al.), 3,683,926 (Suzuki), 4,214,586 (Mericle), 4,233,981 (Schomacher), 4,366,819 (Kasler), 4,368,736 (Kasler), 4,470,415 (Wozniak), 4,501,263 (Harbuck), 4,675,008 (Tretbar), 4,512,761 (Raible), 4,552,148 (Hardy, Jr. et al.), 4,721,109 (Healy), 4,753,236 (Healy), 4,769,029 (Patel), 4,851,001 (Taheri), 4,816,028 (Kapadia et al.), 4,854,318 (Solem et al.), 4,930,502 (Chen), 4,931,057 (Cummings et al.), 4,957,499 (Lipatov et al.), 5,156,619 (Ehrenfeld), 5,123,908 (Chen), 5,192,289 (Jessen), 5,250,058 (Miller), 5,222,963 (Brinkerhoff et al.), 5,330,490 (Wilk et al.), 5,346,501 (Regula et al.), 5,364,389 (Anderson), 5,399,352 (Hanson), 5,425,738 (Gustafson et al.), 5,425,739 (Jessen), 5,443,497 (Venbrux), 5,445,644 (Pietrafitta et al.), 5,447,514 (Gerry et al.), 5,456,712 (Maginot), 5,456,714 (Owen), 5,503,635 (Sauer et al.), 5,509,902 (Raulerson), 5,571,167 (Maginot), 5,586,987 (Fahy) and 5,591,226 (Trerotola et al.).
In our copending U.S. patent application Ser. No. 08/861,584 filed on May 22, 1997 entitled Anastomosis System And Method of Use, which is assigned to the same assignee as this invention and whose disclosure is incorporated by reference herein (hereinafter the "'584 application"), there is disclosed and claimed anastomosis systems and methods of use which overcome many of the disadvantages of the prior art.
Notwithstanding the inventions of the '584 and '682 applications, a need is still deemed to exist for effecting the bypass of two or more vessels, ducts, lumens or hollow organs by means of a common anastomosis connector.